Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury
- Conditions
- Acute Lung InjuryAcute Respiratory Distress Syndrome
- Registration Number
- NCT00521625
- Lead Sponsor
- St. Justine's Hospital
- Brief Summary
PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in children with an acute lung injury (ALI). The objective of the study is to describe mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily clinical practice is heterogenous among pediatric intensivists as few pediatric data exists on optimal mechanical ventilation strategies in this group of patients. Furthermore, different strategies may affect patient outcome.
- Detailed Description
INTRODUCTION Few pediatric data exists on the ventilation mode and parameters that would provide the greatest benefit with the least risk to an individual pediatric patient with Acute Lung Injury (ALI). Current expert opinion is that it is reasonable to follow adult recommendations and to adapt clinical management in children according to adult data. In the absence of consensus and established guidelines for mechanical ventilation in children with ALI, we believe that the daily clinical practice in pediatric intensive care units is subject to great variations according to the experience, comfort and knowledge of the attending intensivist.
METHODS Objective: Describe invasive and non-invasive mechanical ventilation in pediatric cases of ALI.
Hypothesis: There is an important variability in the observed practice pattern of mechanical ventilation in pediatric cases of ALI.
Design: An international cross-sectional epidemiologic study in Pediatric Intensive Care Units on the observed practice pattern of invasive and non-invasive mechanical ventilation in children with ALI.
Setting: Pediatric Intensive Care Units in Canada, United States, Europe.
Patients: Patients less than 18 years old on invasive or non-invasive mechanical ventilation with a diagnosis of ALI on the day of the study.
Measurements: Demographic data on included patients; their underlying chronic disease and acute disease leading to non-invasive mechanical ventilation or intubation and mechanical ventilation; data on mechanical ventilation mode and parameters, vital signs, lab results, radiographic findings, treatments, complications of mechanical ventilation will be recorded every 6 hours for 24 hours. A web based case report form will be developed.
Sample size: We plan to conduct the study on isolated days at least one month apart until we reach 200 patients with ALI, to include at least 10 patients on high frequency ventilation. We estimate that with 5 days of study in 70 centers we should reach this number.
FUTURE CONSIDERATIONS We believe this study will provide important data on the actual mechanical ventilation strategies in pediatric patients with ALI. The next step will be to conduct a prospective international study on mechanical ventilation strategies and to follow patients prospectively during the whole course of their mechanical ventilation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
-
Child on invasive mechanical ventilation administered through an endotracheal tube or a tracheostomy tube, or on non-invasive mechanical ventilation administered through a nasal or facial mask or a nasal canula or helmet at 9 a.m. on the day of the study.
-
Presence of ALI as estimated by the attending physician:
- Onset of hypoxemia was acute
- Bilateral infiltrates on chest X-Ray
- No clinical evidence of congestive heart failure
- Sustained hypoxemia defined as:
PaO2(mmHg)/FiO2 ratio ≤ 300 or PaO2(kPa)/FiO2 ≤ 40
If no arterial canula or no arterial blood gas:
SpO2/FiO2 ≤ 320 with SpO2 < 0.98 (10)
- Post conceptional age < 42 weeks
- Age > 18 years
- Non-corrected cyanotic congenital heart disease or evidence of extra-pulmonary right to left shunt
- Withdrawal/withholding of care
- Brain death
- No consent, if required
- Patient on ECMO
- Already included in this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (57)
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Paola Childrens Hospital
🇧🇪Antwerp, Belgium
Penn State Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
Darmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
CHU Nantes
🇫🇷Nantes, France
Children's Hospital of Austin
🇺🇸Austin, Texas, United States
Akademisches Lehrkrankenhaus
🇦🇹Feldkirch, Austria
McMaster Children's Hospital
🇨🇦Hamilton, Canada
Kinderzentrum im Klinikum Nürnberg
🇩🇪Nurnberg, Germany
University Children's Hospital
🇩🇪Tuebringen, Germany
Medical University of Vienna
🇦🇹Vienna, Austria
Hôpital SteJustine
🇨🇦Montreal, Quebec, Canada
The Children's hospital Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Hôpital Robert-Debré
🇫🇷Paris, France
Montreal Children' Hospital
🇨🇦Montreal, Quebec, Canada
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
The Wilhelmina Children's Hospital
🇳🇱Utrecht, Netherlands
Ospedali riuniti di Bergamo
🇮🇹Bergamo, Italy
CHU Lille
🇫🇷Lille, France
Padua University Hospital
🇮🇹Padova, Italy
University Clinic Frankfurt
🇩🇪Frankfurt, Germany
Cruces Hospital
🇪🇸Bilbao, Spain
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
Necker
🇫🇷Paris, France
Astrid Lindgren Children's Hospital
🇸🇪Stockholm, Sweden
Azienda Ospedaliera di Verona
🇮🇹Verona, Italy
Hospital Sant Joan de Déu-Hospital Clinic
🇪🇸Barcelona, Spain
Hospital Universitario Central de Asturias
🇪🇸Oveido, Spain
Children's Hospital StAugustin
🇩🇪St Augustin, Germany
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostella, Spain
The Queen Silvia Children's Hospital
🇸🇪Goteborg, Sweden
Stollery Children's Hospital
🇨🇦Edmonton, Canada
BC Children's Hospital
🇨🇦Vancouver, Canada
The Children's Hospital
🇺🇸Denver, Colorado, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
CHU Pontchaillou
🇫🇷Rennes, France
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Texas Childrens Hospital
🇺🇸Houston, Texas, United States
Children's Hospital at Oakland
🇺🇸Oakland, California, United States
Kentucky Children's Hospital
🇺🇸Lexington, Kentucky, United States
UMAss Memorial Medical Center
🇺🇸Worchester, Massachusetts, United States
Children's Hospital
🇨🇭Geneva, Switzerland
Children's Hospital of Western Ontario
🇨🇦London, Canada
Hospital universitario de Salamanca
🇪🇸Salamanca, Spain
General University Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Bristol Children's Hospital
🇬🇧Bristol, United Kingdom
Hospital Infantil La Fe
🇪🇸Valencia, Spain
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Belgium
New York Presbyterian Hospital
🇺🇸New York, New York, United States